Stem Cell Research Heads for a Renaissance

By Rick Weiss, Science Progress. Posted November 24, 2008.

New stem cell therapies may be a step closer to being tested in humans.

Ten years to the month after James Thomson at the University of Wisconsin announced in the journal Science his discovery of human embryonic stem cells, scientists and officials from the Food and Drug Administration gathered in Washington last week to talk about the prospects of starting the first human clinical trials of the high-profile cells.

At a public meeting hosted by the National Academies, scientists discussed results from the latest animal studies suggesting that the cells, after proper treatments in laboratory dishes, show promise for their ability to rebuild scarred cardiac muscle after a heart attack, replace lost brain cells in Parkinson's disease, and regenerate the parts of the pancreas that go awry in diabetes. In response, an FDA official urged them to move the research onward but also noted, as gently as she could, that they could still expect to face some significant hurdles before getting a green light to try their fledgling therapies in patients.

The scientists were not taken completely by surprise about the regulatory labyrinth ahead. Most were already well aware of Geron Corp.'s repeated announcements that it was on the verge of starting the world's first human embryonic stem cell-based clinical trial -- announcements that in every case have been followed by less-loudly-trumpeted updates noting that FDA-related delays had set those start dates back. The Menlo Park, Calif.-based company, which wants to inject partially matured embryonic stem cells into the spinal cords of paralyzed people, has conducted tests on nearly 1,000 rodents, filed some 21,000 pages of data to the regulatory agency, and distributed a compelling video showing partially paralyzed mice walking again after getting the cells. But the nearly decade-long road to approval wends onward still.